Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 40 mg and 80 mg) |
Drug Class | Angiotensin II receptor blockers |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of hypertension in adults to lower blood pressure, either alone or in combination with other antihypertensive agents.
Latest News
Summary
- Edarbi (azilsartan medoxomil) is indicated for the treatment of hypertension in adults to lower blood pressure, either alone or in combination with other antihypertensive agents.
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Azilsartan Medoxomil Efficacy: Azilsartan medoxomil (20-80 mg) showed superior efficacy in reducing both office and 24-hour ambulatory systolic and diastolic blood pressure compared to other angiotensin-receptor blockers (ARBs), with an 80 mg dose having a 99% probability of being the most effective in its class. In Japanese patients, azilsartan was more effective in reducing blood pressure than candesartan, irbesartan, losartan, olmesartan, telmisartan, and valsartan.
- Combination Therapy Effectiveness: A combination of azilsartan medoxomil with chlorthalidone (AZL-M/CLD) was more effective in reducing clinic systolic blood pressure than azilsartan medoxomil with hydrochlorothiazide. In Asian hypertensive patients, the azilsartan-amlodipine combination had the highest odds ratio (OR 5.2) for treatment response compared to other ARB-amlodipine combinations and amlodipine monotherapy.
- Subgroup Effectiveness: Azilsartan showed superior blood pressure reduction in Japanese hypertensive patients and was particularly effective in chronic kidney disease patients when combined with chlorthalidone. The azilsartan-amlodipine combination therapy demonstrated the most favorable treatment response in Asian patients with uncomplicated hypertension.
- The most frequently reported adverse events with azilsartan medoxomil were dizziness, headache, fatigue, upper respiratory tract infection, and urinary tract infection. The combination of azilsartan medoxomil with chlorthalidone was associated with higher serum uric acid and lower potassium levels compared to hydrochlorothiazide.
- All ARB-amlodipine combinations, including azilsartan-amlodipine, had safety profiles comparable to amlodipine monotherapy. The telmisartan-amlodipine combination had a significantly lower incidence of treatment-emergent adverse events compared to amlodipine monotherapy.
- Azilsartan demonstrated superior efficacy in hypertensive Japanese patients compared to other ARBs; the azilsartan medoxomil-chlorthalidone combination was more effective in blood pressure reduction for chronic kidney disease patients, and the azilsartan-amlodipine combination therapy showed the highest efficacy in treatment response among Asian hypertensive patients receiving ARB-amlodipine combinations or amlodipine monotherapy.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Edarbi (azilsartan medoxomil) Prescribing Information. | 2022 | Azurity Pharmaceuticals Inc., Worburn, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). | 2023 | Journal of Hypertension |
RSSDI Guidelines for the management of hypertension in patients with diabetes mellitus. | 2022 | International Journal of Diabetes in Developing Countries |
Blood Pressure Targets in Adults With Hypertension: A Clinical Practice Guideline From the AAFP. | 2022 | American Family Physician |
Hypertension Canada’s 2020 comprehensive guidelines for the prevention, diagnosis, risk assessment, and treatment of hypertension in adults and children. | 2020 | Canadian Cardiovascular Society |